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Compliance Program

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 [[Compliance Program]] | [[Compliance Hotline]] | [[Investigations by Third Parties]] | [[Research Integrity]] | [[Export Control]] | [[Code of Conduct]] | [[Use of Human Anatomical Material]] | [[Clinical Research and Clinical Trial Professional and Technical Fee Billing]] | [[Contracts]] | [[Conflict of Interest]] | [[Red Flag Identity Theft Prevention Program]] | [[Principles of Financial Stewardship]] | [[Human Tissue Use and Transfer]] | [[Disclosing Foreign Support and International Research PolicyActivities]] | [[Health Care Vendor Interactions]] | [[Internal AuditCredit Hour Definition]] | [[Credit Hour DefinitionWhistleblower]]
<br /><br />
Policy No.: '''8000'''<br />
Effective Date: '''11/01/06'''<br />
Revised Date: '''0308/0918/17 DRAFT21'''<br />Reviewed Date: '''0308/0918/1721'''<br />
<br />
<big>'''Compliance Program Policy'''</big>
== Basis for Policy ==
The purpose of the Compliance Program and Committee is to identify UNMC’s key compliance risks, as well as make recommendations and implement solutions, policies, procedures and standards of conduct to ensure that UNMC complies with all applicable federal, state and local laws and regulations; and University of Nebraska and UNMC Policies and Procedures. In support of this purpose, UNMC’s Compliance Program will designate a chief compliance officer and a compliance committee whose responsibilities will include the following: to provide for or conduct effective training and education, develop effective lines of communication, and conduct internal monitoring and auditing reviews for adherence to policies and procedures. The University of Nebraska Medical Center (UNMC) Compliance Program consistent with UNMC Policy No. 8006, [[Code of Conduct]], mandates that all UNMC faculty, staff, and students comply with: all applicable federal, state and local laws; all relevant regulations; and University of Nebraska and UNMC Policies and Procedures.
== Compliance Program Structure ==
[[File:Compliance-Flowchart3flowchart-108-175-2020.jpg]]===Associate Senior Vice Chancellor for ComplianceAcademic Affairs===The Associate Vice Chancellor for Compliance reports directly to the Senior Vice Chancellor for Academic Affairs and is responsible for overseeing the development and implementation of the policies, procedures and practices necessary to effect compliance with federal, state, and local laws and regulations; and University of Nebraska and UNMC Policies and Procedures.===Chief Compliance Officer===The Chief Compliance Officer shall report to the Associate Senior Vice Chancellor of for Academic Affairs for Compliance, but has the authority to communicate directly with the Chancellor or Vice Chancellors for Academic Affairs, Business and Finance, Research, Deans , the Audit, Risk and Compliance Committee of the Board of Regents or others on compliance matters , which include, but are not limited to:
*coordinate with subject matter experts to analyze laws and regulations applicable to UNMC to ensure compliance;
*monitor day-to-day compliance activities;
*oversee visits by regulatory agencies and responses to inquiries and investigations;
*report compliance matters directly to the UNMC Chancellor’s Council;
*coordinate with the Associate General Counsel for Health Care on legal issues;*coordinate with the Director of Internal Auditand Advisory Services;
*coordinate with the Information Security Officer;
*coordinate with the University Compliance Officer and other campus compliance officers;
*respond to compliance hotline calls;
*participate on the University Compliance Council;*disseminate information to support compliance and training on the Compliance Program;and*chair the compliance committeeCompliance Committee.
===Compliance Committee===
The Compliance Committee assists the Chief Compliance Officer with the above duties and helps manage the Compliance Program. The Compliance Committee shall seek to leverage the compliance efforts of each area and avoid duplication of effort. The Compliance Committee shall analyze UNMC’s key risk areas, and monitor and promote compliance. The Compliance Committee shall oversee and monitor department response to identified risks as identified by the Internal Audit Director’s annual audit plan Chancellor's Risk Assessment as well as data generated through monitoring and individual reporting.
The Compliance Committee shall meet no less than quarterly. The Compliance Committee shall be composed of at least the following representatives who shall be responsible for the overseeing compliance and assist the Chief Compliance Officer with managing the Compliance Program: *Chief Compliance Officer *Associate General Counsel for Health Care
*Export Control Compliance Officer
*Human Resources Director
*Information Security Officer
*Chair of the Institutional Review Boardor Compliance designee
*Executive Director, Environmental Health & Safety
*Intellectual Property Director
*Director Internal Audit Directorand Advisory Services
*Nebraska Medicine Compliance Officer or Compliance Representative for Nebraska Medicine
*Privacy Officer
*Controller
*Financial Compliance and Cost Analysis
*Sponsored Programs Administration
*Sponsored Programs Accounting
*Director of Procurement
*Chief Student Affairs Officer
*LibraryThe Compliance Committee or Chief Compliance Officer may request reports annually from certain representatives and others to address compliance issues as necessary. The purpose of the reports will be to:
*develop policies related to compliance;
*establish compliance training programs;
*assist with identifying areas of potential compliance vulnerabilities;
*assist with understanding the compliance risks and related regulations and laws; and*assist with response to alleged violation of rules, regulations, policies, procedures , and other functions as needed to enforce this policy.<br />
Representatives would be from the following areas:
*NU Director of Internal Auditand Advisory Services
*Biosafety
*Child Health Research Institute (CHRI)
*College of Dentistry
*College of Medicine
*College of Pharmacy
*College of Public Health
*College of Allied HealthProfessions*Graduate Studies
*UNMC Physicians
*Comparative Medicine/Institutional Animal Care and Use Committee
*Munroe-Meyer Institute
*Environmental Health & Safety
*Student ServicesSuccess
*Others as necessary
 
==Compliance Responsibilities==
[httphttps://www.unmc.edu/academicaffairs/compliance/areas/ Compliance Areas]<br />
Compliance responsibilities shall be established per UNMC and/or Board of Regents policies and procedures linked and referenced below:
{| class="wikitable"
| Code of Conduct || UNMC Policy No. 8006, [[Code of Conduct]]
|-
| IRB || [httphttps://www.unmc.edu/irb/ Institutional Review Board]https://www.unmc.edu/ibc/
|-
| IACUC || [httphttps://wwwinfo.unmc.edu/iacuc/ Institutional Animal Care and Use Committee], BOR Policy 3.2.8
|-
| Conflict of Interest || UNMC Policy No. 1049, [[Outside Employment]], UNMC Policy No. 8010, [[Conflict of Interest]], UNMC Policy No. 8015, [[Health Care Vendor Interactions]]
|-
| Clinical Trial Billing || UNMC Policy No. 8008, [[Clinical Trial Professional and Technical Fee Billing]]
| Research Integrity || UNMC Policy No. 8003, [[Research Integrity]]
|-
| Sponsored Programs Administration and , Sponsored Programs Accounting and Financial Compliance & Cost Analysis || UNMC Policy No. 3001, [[Sponsored Programs]], UNMC Policy No. 6100, [[Direct CostSponsored Programs Costing]], UNMC Policy 6101, [https://wikiNo.unmc.edu/index.php/Facilities_and_Administrative_Cost Facilities and Administrative, F&A) Cost], UNMC Policy 6102, [[Institutional Base Salary]], UNMC Policy 6103, [https://wikiNo.unmc.edu/index.php/Unallowable_Cost_Policy Unallowable Cost], UNMC Policy 6104, [[Sponsored Project Cost Share]], UNMC Policy No. 6105, [[Effort Certification]], UNMC Policy No. 6106, [[Cost Transfer]], UNMC Policy No. 6107, [[Service Center]], UNMC Policy No. 6108, [[https://wiki.unmc.edu/index.php/Subrecipient_Policy Subrecipient], UNMC Policy No. 6110, [[On-Campus and Off-Campus Indirect Cost Rates on Federally Sponsored Projects]]
|-
| '''Environmental and Safety Compliance'''||
|-
| Safety || [httphttps://www.unmc.edu/ehs/safety/ UNMC Environmental Health & Safety Department], UNMC Policy No. 2000, [[Safety]]
|-
| Radiation Safety || [httphttps://www.unmc.edu/ehs/ UNMC Environmental Health & Safety Department]
|-
| Bloodborne Pathogens || [httphttps://www.unmc.edu/academicaffairs/compliance/areas/infection.html Infection Control], UNMC Policy No. 2004, [[Bloodborne Pathogens Exposure]]
|-
| Biosafety || [httphttps://www.unmc.edu/ibc/ Institutional Biosafety Committee], UNMC Policy No. 2005, [[Waste Handling]], [httphttps://infowww.unmc.edu/safetyehs/safety-officebiosafety/biohazardousbiohazard-waste/2005-waste-handling-attachments-2014index.pdf Biohazardous htmlBiohazardous Waste Handling]
|-
| Chemical Safety || [httphttps://www.unmc.edu/ehs/ UNMC Environmental Health & Safety Department], UNMC Policy No. 2002, [https://wiki.unmc.edu/index.php/Shipping_Hazardous_Materials Shipment of Hazardous Materials or Dangerous Goods]
|-
| Security || [httphttps://info.unmc.edu/safety/campus-security/index.html UNMC Campus Security]
|-
| '''Intellectual Property''' ||
| '''Privacy and Information Security'''||
|-
| Privacy, Confidentiality , and Information Security|| UNMC Policy No. 6045, [https://wiki.unmc.edu/index.php/Privacy/Confidentiality Privacy, Confidentiality and Information Security]
|-
| Use and Disclosure of Protected Health Information|| UNMC Policy No. 6054, [[Use and Disclosure of Protected Health Information]]
| Computer Use and Information Security || UNMC Policy No. 6051, [https://wiki.unmc.edu/index.php/Computer_Use/Electronic_Information Computer Use and Electronic Information Security]
|-
| Export Control || UNMC Policy No. 8005, [[Export Control]], UNMC Policy No. 8014, [[Disclosing Foreign Support and International Activities]]
|-
| Human Resources || [httphttps://www.unmc.edu/employmenthuman-resources/about/contact-hr.html Human Resources]
|-
| Internal Audit || UNMC Policy No. 8016, [University of Nebraska Internal Audit Charter and [https://nebraska.edu/offices-policies/internal-audit-and-advisory-services UNMC Internal Audit]and Advisory Services Webpage]
|-
| Student Services Success || [https://wikiwww.unmc.edu/index.phpstudent-success/Student_Policies Student ServicesSuccess], [https://wwwcatalog.unmc.edu/studentservices/_documents/Handbook.pdf Student HandbookUNMC CourseLeaf Catalog] [https://www.unmc.edu/academicaffairs/compliance/matrix.html Compliance Matrix], [https://www.unmc.edu/studentservicesstudent-success/academic-records/ferpa/ .html FERPA Information]
|-
| Title IX || UNMC Policy No. 1099, [[Non-Discrimination and Harassment]], UNMC Policy No. 1107, [[Sexual Misconduct]]
|-
| Family Educational Rights and Privacy Act (FERPA) || [https://wiki.unmc.edu/index.php/Student_Policies Student ServicesPolicies], [httphttps://www.unmc.edu/studentservicesstudent-success/ academic-records/ferpa.html FERPA Information]
|-
| False Claims Act || Contact the Chief Compliance Officer (see also the UNMC Compliance Hotline , 1-866844-568384-54309584 or www.nebraska.ethicspoint.com), [https://www.unmc.edu/academicaffairs/_documents/compliance/False_Claims_Act.pdf False Claims Act 31 U.S.C. §§ 3729-3733]
|-
| Foreign Corrupt Practices Act || Contact the Chief Compliance Officer (see also the UNMC Compliance Hotline , 1-866844-568384-54309584 or www.nebraska.ethicspoint.com), [https://www.unmc.edu/academicaffairs/_documents/compliance/foreign_corrupt_practices_act.pdf Foreign Corrupt Practices Act (FCPA) 15 U.S.C. §§ 78dd-1, et seq.]
|}
==Compliance Committee Meetings==
The purpose of Compliance Committee meetings shall be to analyze, assess, manage, coordinate , and develop corrective action(s) related to compliance risks identified for the purpose of compliance with UNMC’s Code of Conduct, University of Nebraska and UNMC Policies and Procedures.
The Compliance Office shall complete meeting minutes and maintain them on file for no less than seven years. The draft meeting minutes shall be distributed to committee members, vice chancellors, college deans and executive directors to inform UNMC leadership about compliance activities.
==Compliance Hotline==
A UNMC compliance hotline (1-844-384-9584 or www.nebraska.ethicspoint.com) has been established to provide individuals with an additional communication channel to report compliance concerns. The Chief Compliance Officer shall investigate concerns and take corrective action in response to identified issues. For additional information, see UNMC Policy No. 8001, [[Compliance Hotline]].
==Compliance Training==
All University of Nebraska Medical Center employees(including visitors and non-faculty volunteers), students (including visiting studentsand visitors), and faculty (including but not limited to courtesy, adjunctfaculty, visitors and volunteers) must be knowledgeable of and comply with laws and regulations related to their duties or field of study as determined by the Chief Compliance Officer and Compliance Committee.
Mandatory compliance training is required of UNMC staff and students. All UNMC invited visitors on campus for seven (7) or greater days, have access to UNMC software/databases or access to the UNMC Campus (ID Badge) must complete all mandatory compliance training required of UNMC faculty, staff and students. It is the individual's responsibility to complete the compliance training requirements listed at httphttps://www.unmc.edu/academicaffairs/compliance/training-requirements/index.htmland assigned via the UNMC Learning Platform. Failure to complete the training requirements will be grounds for corrective action up to and including dismissal or termination of employment. Delinquency notices will be sent according to the guidelines below:
{| class="wikitable" style ="text-align:center"
| 30 Days || E-mail/verbal notice from unit management || E-mail/verbal notice from Dean’s office
|-
| 60 Days || Communication from Human Resources || Letter from Senior Vice Chancellor for Academic Affairs; records placed on hold
|-
| 90 Days || Notification to Dean, access removed from all UNMC resources except Blackboard Canvas until training has been completed ||
|-
|}
*For a complete listing of Contacts and Compliance Topics see the [https://www.unmc.edu/academicaffairs/compliance/matrix.html Compliance Matrix] for details.
*UNMC Policy No. 1003, [[Drug Free Campus]]
*UNMC Policy No. 1049, [[Outside Employment]]
*UNMC Policy No. 1099, [[Non-Discrimination and Harassment]]
*UNMC Policy No. 2002, [https://wiki.unmc.edu/index.php/Shipping_Hazardous_Materials Shipment of Hazardous Materials or Dangerous Goods]
*UNMC Policy No. 2004, [[Bloodborne Pathogens Exposure]]
*UNMC Policy No. 6100, [[Sponsored Programs Costing]]
*UNMC Policy No. 6102, [[Institutional Base Salary]]
*UNMC Policy No. 6104, [[Sponsored Project Cost Share]]
*UNMC Policy No. 6105, [[Effort Certification]]
*UNMC Policy No. 6106, [[Cost Transfer]]
*UNMC Policy No. 6107, [[Service Center]]
*UNMC Policy No. 6108, [https://wiki.unmc.edu/index.php/Subrecipient_Policy Subrecipient]
*UNMC Policy No. 6110, [[On-Campus and Off-Campus Indirect Cost Rates on Federally Sponsored Projects]]
*UNMC Policy No. 6036, [[Reproducing Copyrighted Materials]]
*UNMC Policy No. 6045, [https://wiki.unmc.edu/index.php/Privacy/Confidentiality Privacy, Confidentiality and Information Security]
*UNMC Policy No. 8006, [[Code of Conduct]]
*UNMC Policy No. 8010, [[Conflict of Interest]]
*UNMC Policy No. 8014, [[Disclosing Foreign Support and International Activities]]
*UNMC Policy No. 8015, [[Health Care Vendor Interactions]]
 
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